Vaccine -diphthEria -tetaNus -Acellular pertUssis-inactivated polioviruS (Venus)

Boryung

Status and phase: Completed; Phase 3

Conditions: Poliomyelitis; Diphtheria; Pertussis; Tetanus

Treatments: Biological: DTaP vaccine and IPV vaccine; Biological: DTaP-IPV combination vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02458183

BR-DTPP-CT-301

Details and patient eligibility

About

The objective of this study is to assess the immunogenicity and safety of the DTaP-IPV combination vaccine compared with those of separate DTaP and IPV vaccines administered to healthy infants at 2, 4, and 6 months of age.

Full description

A multinational, multicenter, randomized, comparative, open-label, phase 3 study

Primary Objective: To assess the vaccine response rates after the three-dose primary vaccination Secondary Objectives: To measure the antibody titer after the three-dose primary vaccination and to assess the safety of the investigational products

Enrollment: 476 patients

Sex: All

Ages: 7 to 10 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Parent/guardian (legally authorized representative) has given voluntary written consent to the subject's participation after being fully informed of the purpose, methods, risks, and benefits of the study.
• Male and female infants reaching at least 7 weeks of age on the day of first dose of investigational product.
• Male and female infants who are identified to be healthy based on physical examination and medical history.

Exclusion criteria

• Subjects who have acute febrile illness with tympanic temperature of ≥38.0 ℃ on the day of vaccination.
• Subjects who have moderate or severe acute disease (regardless of fever).
• Subjects who have any history of diphtheria, tetanus, pertussis, or poliomyelitis.
• Subjects who have major congenital defects.
• Subjects who show any evidence of continuous hematologic, hepatic, cardiac, re-nal, or respiratory disease.
• Subjects who have abnormalities in the immune system, or congenital/acquired immune deficiency.
• Subjects who received immunosuppressive dose of systemic corticosteroids thera-py within 30 days before the vaccination.
• Subjects who are likely to have adverse side effects on central nervous system be-cause of the subjects' family history of genetic diseases in central nervous system such as progressive neurological problems or epilepsy.
• Subjects who are allergic to the ingredients of the investigational products.
• Subjects who have received immunoglobulins or blood products or plan to get those medications.
• Subjects who have received vaccines other than those allowed in the protocol or plan to get those prohibited vaccines during the study period.
• Subjects who are currently participating or planning to participate in other clinical studies during the study period.
• Other ineligible conditions judged at the discretion of principal investigators or subinvestigators.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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476 participants in 2 patient groups

DTaP-IPV combination vaccine

Experimental group

Description:

Dosage and administration: A 0.5-mL dose is administered intramuscularly in the anterol-ateral aspect of right thigh at the age of 2, 4, and 6 months

Treatment:

Biological: DTaP-IPV combination vaccine

DTaP vaccine and IPV vaccine

Active Comparator group

Description:

Product name: : Boryung DTaP Vaccine Inj. (Prefilled syringe) (Absorbed diphtheria, tetanus toxoid, and purified pertussis combination vaccine) Dosage and administration: A 0.5-mL dose is administered 3 times intramuscularly in the anterolateral aspect of right thigh at the age of 2, 4, and 6 months. Product name: IPVAX INJ. PREFILLED SYRINGE INJ. Dosage and administration: A 0.5-mL dose is administered intramuscularly in the anterol-ateral aspect of left thigh at the age of 2, 4, and 6 months.

Treatment:

Biological: DTaP vaccine and IPV vaccine